Maquet Cardiovascular, LLC Recalls
Showing 1-20 of 21 recalls
Maquet Getinge-BEQ-TOP 15800 TUBING PACK Material: 3000065087
Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
Maquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 1 888 627 8383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time. On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQ TOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051.
INTERGARD Woven Vascular Graft is a woven polyester graft coated with a bovine collagen. It has an external velour surface and non-velour inner surface. The device is available in straight tubes and bifurcated configurations, as well as hemabridge, aortic arch, thoracic aortic graft, and cardioroot configurations designed for use on the thoracic aorta
Mislabeled: Product labeled as Intergard Woven Straight graft REF IGW0032-30, D: 8 mm, L: 30 cm, contained an Intergard Woven Straight graft of D: 32 mm and L: 30 cm
Intervascular SAS / Getinge issued Urgent Medical Device Removal letter via mail on April 29, 2022. Letter stated reason for recall, health risk and action to take: Please examine your inventory immediately to determine if you have the INTERGARD Woven Straight graft, Ref Number IGW0032-30, Lot 20L12, SN 1303435656. Please make sure that the affected product is segregated in a secure storage place to prevent any use of the product. Should you have the unused affected product, you are eligible for credit upon receipt of the Response Form (see page 4). Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping instructions to return any affected product. Pack the product to be returned with the appropriate return documents. Whether you have affected product or not, please complete and sign the attached URGENT MEDICAL DEVICE REMOVAL RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to INTERGARDwovengraft.act@getinge.com or by FAX to 1-877-485-5541
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead of a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1260004700; 18 mm x 9 mm; REF Number M002020851890 or a Hemashield Gold Knitted Microvel Double Velour Bifurcated Vascular Graft; SN 1259882880; 18 mm x 9 mm; Ref Number M002020851890.
And URGENT MEDICAL DEVICE REMOVAL notification letter dated 12/1/21 was sent to customers. Actions to be taken: " If you have already implanted one of the above-mentioned devices, kindly notify us as soon as possible by contacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted shortly by our Medical Affairs Officer in order to discuss the appropriate follow up. " Please examine your inventory immediately to determine if you one of the Hemashield Gold Knitted Bifurcated Vascular Graft with a Serial Number matching those listed on page 1 of this letter. " Should you have un-used affected product, you are eligible for credit or a replacement at no cost to your facility upon receipt of Response Form (see page 4). " To get your free replacement Graft we need you to provide a ship to contact and your acknowledgment on page 4. " Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping instructions to return any affected product. " Pack the product to be returned with the appropriate return documents. " Whether you have affected product or not, please complete and sign the attached URGENT MEDICAL DEVICE REMOVAL RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to Hemashield.Intervascular@getinge.com or by FAX to 877-258-1332. " Please forward this information to all current and potential Hemashield Gold Knitted Microvel double velour vascular graft users within your hopsital / facility. " If you are a distrubutor who has shipped any affected product to customers, please forward this document to their attention for appropriate action. This voluntary recall only affects the product with the serial number and lot number listed on page 1; no other products
HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M002020952070
Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Straight Vascular Graft, D: 7 mm L: 60 cm). Mislabeled product could cause a disruption of the vascular anastomosis in the long term, creating a pseudo-aneurysm
Getinge issued Urgent Medical Device Letter onJanuary 14, 2022, (via FedEx overnight) with adult signature required. Letter states reason for recall, health risk and action to take: Actions to be taken: " If you have already implanted the above-mentioned device, kindly notify us as soon as possible by contacting your Getinge representative or Customer Service (at 1-888-943-8872, options 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. EST. You will be contacted shortly by our Medical Affairs Officer in order to discuss the appropriate follow up. " Please examine your inventory immediately to determine if you have the HEMASHIELD GOLD Product Knitted Microvel Double Velour Straight Vascular Graft (D: 7 mm; L: 60 cm) SN 1318567653, Ref Number M002020952070. " Should you have the un-used affected product, you are eligible for credit upon receipt of Response Form (see page 4). " Please contact Getinge Customer Service at 1-888-943-8872, (press option 2) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request shipping instructions to return any affected product. " Pack the product to be returned with the appropriate return documents. " Whether you have affected product or not, please complete and sign the attached URGENT MEDICAL DEVICE REMOVAL RESPONSE FORM (page 4) to acknowledge this recall and return the completed form to Getinge by e-mailing a scanned copy to Hemashieldgold- Recall.us@getinge.com or by FAX to 8772811346. " Please forward this information to all current and potential Hemashield Gold Knitted Microvel Double Velour Vascular Graft users within your hospital / facility. " If you are a distributor who has shipped any affected product to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or, for technical questions, please contact Customer Service (at 1-888-943-8872, options 2), Monday th
Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.
Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.
On February 14, 2022, a customer notification letter was issued via FedEx. Customers are instructed to quarantine and return all affected product and notify all users within the hospital/facility. Please note affected lot numbers appear on the device package only. If the packaging has been discarded, the affected devices can be identified by Device Component Lot number, which is etched onto all 3 device components on side of handle and on underside above each pin. Customers are to complete and return the response form by email or fax. Distributors are to forward this document to customers for appropriate action. If you have any questions, please contact your Maquet Cardiovascular, LLC /Getinge representative or call the Getinge Customer Service at (888) 880-2874, Monday through Friday, between the hours of 6:00a.m. and 5:00 p.m. (Pacific Standard Time)
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Getinge issued a customer notification - Urgent Medical Device Removal on April 7, 2020 via FedEx 2-day delivery with signature required. Letter states reason for recall, health risk, and action to take: Examine your inventory immediately to determine if you have any affected HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Graft and/or HEMASHIELD PLATINUM Woven Double Velour Vascular Graft products. If you have affected product that are listed in attachment 1 on page 5, please remove the affected products from areas of use. "If you have affected product to return, please contact Getinge Customer Support at (888) 9GETUSA / (888) 9438872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization number (RMA) and shipping instructions. Please fill out the customer response form on page 4 with the required information. "Pack the product to be returned with the appropriate return documents and, using the shipping instructions provided. Please arrange for pickup with the designated delivery service provider. Whether you have the affected product or not, please complete and return the form (page 4) to acknowledge this recall by e-mailing a scanned copy to Hemashield2020.ACT@getinge.com or by faxing the form to (973) 807-9205 Questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 9GETUSA / (888) 9438872 (press option 2) between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time.
AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
The firm, Maquet/Getinge, issued "URGENT MEDICAL DEVICE RECALL - REMOVAL" letters mailed to customers on January 24, 2019 via FedEx Priority Overnight,. The letters identified the issue, the product, actions to take and health risk. The customers were instructed to:Please examine your inventory immediately to determine if you have any of the affected; stop using the affected lot numbers of the Axius Blower Mister; remove and properly label any identified affected product, and keep it in quarantine in a secure location to preclude being used. Should you have un-used affected product you are eligible for either a replacement or credit. Please contact Geting Customer Service at 1-888-627-8383 (press option 2, then option 4) to request a return authorization (RMA) and shipping instructions to return any affected product. Complete and sign the MEDICAL DEVICE RECALL - REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to blowermister(@qetinge.com or by faxing the form to 1-800-915-0124. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 4), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.
VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply.
Maquet has received several complaints involving the VASOVIEW HEMOPRO VH-3500 which involve the device exhibiting the failure mode of intermittent or no power.
Maquet Inc. issued an Urgent Removal Correction Notice letter dated January 27, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory for affected device. Remove and keep it in a secure location to preclude being used. Customers were asked to complete the Medical Device Removal Response Form and return to Maquet by e-mailing a scanned copy to HemoproPower@getinge.com or by faxing the form to 1-973-629-1518.
Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.
An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device and XPOSE 4 Access Device.
Maquet Inc. issued Recall letters/Acknowledgement forms dated via Fed-Ex on 8/13/2014.
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
Maquet Cardiovascular sent an Urgent Product Recall Letter dated March 27, 2012, and Urgent Product Recall Acknowledgement to all affected customers . The letter identified the product, the problem, and the action to be taken by the customer. Datascope Corp determined that the best course of action was to replace the affected product. Customers were instructed that they would be contacted by a service representative to make arrangements for the removal and replacement of their affected product. Customers with questions were instructed to contact the US Call Center at 1-800-777-4222. For questions regarding this recall call 973-709-7498.
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470 Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of
Maquet has received an increase in the number of complaints for "self-activated/remains activated/overheats" for the Hemopro VH-30000, "Hemopro 1"
Maquet Inc. sent an Urgent - Medical Device Recall (Removal) Immediate Action Required Letter dated October 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please examine your inventory immediately to determine if you have any of the affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System (HEMOPRO 1) VH-3000 with the lot number(s), as specified above. The VH-3000 catalog number and lot number are located on the package label. Please remove the affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System and place in a secure location. NOTE: VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System HEMOPRO 1 lot numbers not listed are not affected by this recall and should not be removed. HEMOPRO 2 is not affected by this recall. Your MAQUET Cardiovascular Sales Representative will contact you shortly to assist with the completion of the enclosed Acknowledgement Form (Fax Back Form), the return of any affected VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System HEMOPRO 1 product and arrange for necessary replacement. We apologize for any inconvenience this may cause. If you have any questions, please contact your local MAQUET Cardiovascular Sales Representative or MAQUET Customer Service at 1-888-880-2874, Monday through Friday, between the hours of 6:00 a.m. and 5:00 p.m. PST. Thank you for your cooperation and immediate assistance.
Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of t
MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades.
MAQUET sent an "Urgent Medical Device Recall" letter and "Field Recall Response Forms" dated September 20, 2013 to customers via Federal Express. The notification identifies the affected product; informs the customers of the nature of the issue; and advises of potential adverse patient consequences that may occur. The customer is asked to complete and return the Field Recall Response Form. If the customer has questions they are directed to contact their field representative or MAQUET Technical Support (888.627.8383 between 8 am and 5 pm EST Monday through Friday).
ACROBAT Stabilizers- ACROBAT V Vacuum Off-Pump System (OM-91 OOS), ACROBAT SUV Vacuum Off-Pump System (OM-9000S), ACROBAT Mechanical Off-Pump System (OM-6000S) Product Usage: The OM-9100S Acrobat V Vacuum Off-Pump System is intended for use during performance of cardiac surgical procedures through a sternotomy incision. The stabilizer isolates and provides local immobilization of a vessel on the beating heart.
There may be a small perforation in the sterile pouch of select lots of the ACROBAT V, ACROBAT SUV, and ACROBAT Mechanical Stabilizers and the XPOSE 3 and XPOSE 4 Positioners.
Maquet sent an Urgent Device Removal Immediate Action Required letter dated November 16, 2011 and a Field Action Response forms via Federal Express to to affected customers. The letter identifies the problem, product. risk factors and actions to be taken. Customers were instructed to examine their stocks immediately to determine if they have any of the recalled product. If so, discontinue dispensing (distributing) the lot and complete the Field Action Response form attached to complete and fax the attached Field Action Response form. In addition, it provides instructions for how to return the recalled product to MAQUET. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. If you have any questions contact the Recall Hotline Center at 1-888-613-0271. If you have any additional questions, contact your local MAQUET Cardiovascul'ar sales representative or Customer Service at 1-888-880-2874 (6AM -5PM PST).
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up
It has come to the attention of MAQUET that there have been episodes of brief unexpected shutdown, followed by an automatic device restart of the human machine interface (touch screen) of the CARDIOHELP device. The human machine interface (HMI) is the central display of the CARDIOHELP device, where measured values, settings and alarms are displayed and adjusted/confirmed, with the exception of bl
MAQUET sent an Urgent Medical Device Field Correction letters dated March 7, 2013 via Federal Express to all affected customers. The letter identifies the affected product, problem and actions to be taken. Customers are asked to complete and submit the included Customer Fax-back Form. Maquet Service will exchange all affected products with the updated version. For questions MAQUET Customer Service at 888-627-8383 (press option 2, followed by option 2).
Labeling on box reads: MAQUET BEQ-HG 0284 3/8" X 3/8" Connectors, Lot 70041098 but the product packaged inside was MAQUET BEQ-HG 1113 3/16" x 3/16" Connectors, Lot 70041096. The HG 0284 and HG 1113 connectors are packaged sterile as single components in a container holding 20 units. The connectors are designed to be used for performing connections between tubes in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. BEQ-HG Connectors are to be used with
Tubing connectors incorrectly packaged and labeled.
The firm, Maquet, sent a "PRODUCT RECALL URGENT MEDICAL DEVICE CORRECTIVE ACTION" letter dated February 22, 2011 via Federal Express to its customer. The letter described the product, problem and the action to be taken. The customer was instructed to examine their inventory immediately to identify and remove the affected connectors and complete and return the attached RECALL- Device Corrective Action Response Form via fax to Director of Regulatory Affairs at (973) 709-7016 or email: whitney.torning@maquet.com. If you have any additional questions, please contact your local MAQUET Cardiovascular Sales Representative or customer service at 1-800-777-4222.
Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascular patch grafting. The fabric is recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
One unit of Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch which did not meet the internal release criteria for water permeability was distributed.
The firm, Maquet, contacted their sole consignee/customer via telephone informing the customer of the recall and instructing the customer to put the unit to the side. On December 8, 2010 a sales representative visited the site to ensure the unit had been put to the side and to ensure the unit was shipped back to Maquet. If you have any questions, call the Manager, Regulator Affairs at 973-709-7487.
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. Sterile Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
This is an expansion of Recall # Z-866-2010, adding an additional two lots to the recall of EXXCEL soft Stand Wall EPTFE Vascular Grafts due to a labeling mix up.
The firm, MAQUET Cardiovascular, LLC, sent a "DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated March 23, 2010, to all customers via Federal Express. The letter describes the product, problem and action to be taken by customers. The customers were instructed to examine their stock immediately to determine if they have any of the affected product from the lot, discontinue dispensing the lot and complete and return by fax (973-709-6511) the enclosed Field Action Response Form whether or not they have any affected products. Please contact your local MAQUET cardiovascular sales representative or Customer Service at 1-888-880-2874 for the exchange.
VASOVIEW 6 Endoscopic Vessel Harvesting System Manufactured by Maquet Cardiovascular, LLC; 170 Baytech Drive, San Jose, CA 95134. Product Usage: Endoscopic vessel harvesting systems are indicated for use in minimally invasive surgery allowing access for vessel harvesting and are primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
During routine production quality monitoring process, it was found that UV curing adhesive was not used in a limited number of devices.
MAQUET Cardiovascular, LLC, sent an "Urgent Device Removal/Immediate Action Required" letter dated December 17, 2009, to all affected customers. The letter identified the recalled products, the problem, and the actions needed to be taken. The letters asked customers to examine their stocks (inventory) immediately to determine if they had any affected lot numbers and to discontinue dispensing (distributing) the lot. The letter states that customers are to complete the attached Field Action Response form regardless of whether or not the affected products are located in their inventory. Distributors are instructed to provide the same instructions to their customers supplied with the recalled products. The letter instructed all users to return all unused affected products to MAQUET. For customer's convenience, all affected products that are returned may be exchanged with other unaffected VASOVIEW Endoscopic Vessel Harvesting System by overnight delivery. Questions should be directed to MAQUET Cardiovascular sales representative or Customer Service at 1-888-880-2874.
Hemashield Gold Woven Double Velour Vascular Branch Graft
Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.
Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.
Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
The firm, MAQUET Getinge Group, sent an "URGENT DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 5, 2010, to all customers via Federal Express. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to immediately examine their stocks to determine if they have any of the affected product, if found, discontinue dispensing (distributing) the lot and complete the Field Action Response Form; immediately contact accounts if they acted as a distributor, and acknowledge receipt of this notification whether or not they have any affected products by completing the Field Action Response Form via fax to (U.S.): 1-888-899-2874. If you have any additional questions, please contact your local MAQUET Cardiovascular sales representative or our Customer Service at 1-888-880-2874.